Tofacitinib
Small molecule targets JAK1, JAK3, STAT3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 14 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (7) | US (FDA) | XELJANZ | — | 2013-11-18 – 2026-03-06 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | XELJANZ XR | — | 2017-08-22 – 2021-12-14 | fda.gov ↗ |
| Approved | EU (EMA) | Xeljanz | — | 2017-03-22 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Xeljanz | — | 2013-07-25 | europa.eu ↗ |
| Approved | US (FDA) | XELJANZ | — | 2012-11-06 | fda.gov ↗ |
Trials 208 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 07 trials | ||||||
| Phase 0 | NCT07055529 | Jun → Dec 2026 expected | generalized vitiligo | Hayat Abad Medical Complex, Peshawar | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06689982 | Dec 2024 → Dec 2025 overdue | amyotrophic lateral sclerosis | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06119490 | Jul 2023 → Jul 2026 overdue | toxic epidermal necrolysis | Peng Zhang | Recruiting | No outcome recorded |
| Phase 0 | NCT06157905 | Aug 2022 → Feb 2023 | alopecia areata | Services Institute of Medical Sciences, Pakistan | Completed | No outcome recorded |
| Phase 0 | NCT05293119 | May 2022 → May 2023 | vitiligo | Pi Research Consultancy Center, Bangladesh | Unknown | No outcome recorded |
| Phase 0 | NCT04431895 | Jun 2020 → Mar 2024 | generalized myasthenia gravis | Huashan Hospital | Completed | No outcome recorded |
| Phase 0 | NCT03159936 | Apr 2017 → May 2020 | discoid lupus erythematosus, systemic lupus erythematosus | Tufts Medical Center | Terminated | No outcome recorded |
| Phase 143 trials | ||||||
| Phase 1 | NCT06275464 | Jan → Apr 2024 | — | Biora Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05048238 | Sep 2022 → Feb 2024 | cutaneous lupus erythematosus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT04985955 | Jul → Sep 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04468425 | Oct → Dec 2020 | — | TWi Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04338711 | Jun → Sep 2020 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04114461 | Nov → Dec 2019 | — | Hanlim Pharm. Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04111614 | Oct → Dec 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04034238 | Aug 2019 → Dec 2020 | extrahepatic bile duct carcinoma, malignant epithelioid mesothelioma, pancreatic adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT04278391 | Jul → Aug 2019 | — | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 1 | NCT03793439 | May 2019 → Jun 2020 | pulmonary sarcoidosis | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 1 | NCT03910543 | Apr 2019 → Jun 2021 | granuloma annulare, skin sarcoidosis | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT03858725 | Feb → Apr 2019 | rheumatoid arthritis | Chong Kun Dang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT04403776 | Dec 2018 → Feb 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03112148 | Sep → Nov 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03002649 | Jan 2017 → Sep 2020 | dermatomyositis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT02487433 | Jun → Jul 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02193815 | Sep 2014 → Feb 2015 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02084875 | Apr → May 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01513902 | Mar 2013 → Dec 2015 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01731327 | Nov → Dec 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01741493 | Nov 2012 → Dec 2013 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01499004 | Nov → Dec 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01405118 | Jun → Jul 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01262118 | May 2011 → Jan 2012 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01277991 | Feb → Mar 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01101919 | Oct 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01202240 | Sep 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01204112 | Sep → Oct 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01184001 | Sep 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01184092 | Aug → Sep 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01185184 | Aug 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01143805 | Jul → Aug 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01137708 | Jun → Jul 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01023100 | Mar 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00969813 | Nov 2009 → Jan 2010 | liver disorder | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00902460 | Jun → Jul 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00860496 | Jun → Aug 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01743677 | Oct 2007 → Feb 2008 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01745055 | Apr 2005 → Jun 2006 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01740362 | Oct 2003 → Mar 2004 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01710033 | Sep 2003 → Apr 2005 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01710020 | Feb → Jun 2003 | end stage renal failure | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01736696 | Nov 2002 → Apr 2004 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT05487963 | Nov 2022 → Jun 2023 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT05104723 | Aug 2022 → May 2026 | chronic granulomatous disease, inflammatory bowel disease, lung disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT04496960 | May 2021 → Jan 2025 overdue | Sjogren syndrome | National Institute of Dental and Craniofacial Research (NIDCR) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04141904 | Feb 2020 → May 2022 | major depressive disorder | University of Oxford | Terminated | No outcome recorded |
| Phase 1/2 | NCT03288324 | Aug 2017 → Nov 2022 | cutaneous lupus erythematosus, systemic lupus erythematosus | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1/2 | NCT00784719 | Nov 2008 → Oct 2009 | dry eye syndrome | Pfizer | Completed | No outcome recorded |
| Phase 266 trials | ||||||
| Phase 2 | NCT07522801 | Sep 2026 → Dec 2029 expected | — | Philippe ROUSSELOT | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07598643 | May 2026 → Aug 2030 expected | Down syndrome | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT07547930 | Apr 2026 → Dec 2027 expected | disease of orbital part of eye adnexa | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT07530224 | Mar → Dec 2026 expected | — | Shixiu Wu | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07313072 | Mar 2026 → Jan 2027 expected | psoriasis | Hexsel Dermatology Clinic | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07297069 | Jan 2026 → May 2027 expected | ulcerative colitis | Asian Institute of Gastroenterology, India | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281456 | Dec 2025 → Dec 2030 expected | Sjogren syndrome | National Institute of Dental and Craniofacial Research (NIDCR) | Recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06923228 | Apr → Jul 2025 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06698822 | Mar 2025 → Jun 2027 expected | primary cutaneous T-cell lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06810050 | Dec 2024 → Aug 2025 | atopic eczema | CAGE Bio Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06393972 | Jul 2024 → Nov 2025 overdue | toxic myocarditis | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06044844 | Nov 2023 → May 2024 | — | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT05662228 | Jun 2023 → May 2026 | Down syndrome | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT05845723 | Jun 2023 → Jun 2026 overdue | Behcet disease | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05246293 | Aug 2022 → Mar 2024 | interstitial lung disease, rheumatoid arthritis | National Institute of Respiratory Diseases, Mexico | Unknown | No outcome recorded |
| Phase 2 | NCT05165771 | Jul 2022 → Feb 2023 | rheumatoid arthritis | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 2 | NCT05400889 | Jun 2022 → Mar 2023 | idiopathic inflammatory myopathy | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05348213 | May 2022 → Jun 2025 overdue | diffuse large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04768504 | Mar 2022 → Jan 2024 | — | Khashayar Esfahani | Terminated | No outcome recorded |
| Phase 2 | NCT05087589 | Nov 2021 → Jan 2023 | Sjogren syndrome | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04925973 | Jun 2021 → Dec 2023 overdue | ulcerative colitis | McMaster University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04580277 | Jan 2021 → Dec 2022 | pouchitis | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT04799262 | Jan 2021 → Mar 2022 | polymyalgia rheumatica | RenJi Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04246372 | Oct 2020 → Oct 2024 | Down syndrome, alopecia areata, atopic eczema, hidradenitis suppurativa +2 | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 2 | NCT04415151 | Oct 2020 → Feb 2021 | pneumonia | Yale University | Terminated | No outcome recorded |
| Phase 2 | NCT04413617 | Jul 2020 → Feb 2022 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04412252 | Jul → Sep 2020 | COVID-19 | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT04390061 | Jun → Sep 2020 | COVID-19, interstitial lung disease | Marche Polytechnic University | Unknown | No outcome recorded |
| Phase 2 | NCT04750317 | May → Aug 2020 | COVID-19 | I.M. Sechenov First Moscow State Medical University | Completed | No outcome recorded |
| Phase 2 | NCT04332042 | Apr → Jun 2020 | interstitial lung disease | Marche Polytechnic University | Unknown | No outcome recorded |
| Phase 2 | NCT03681275 | Sep 2019 → Nov 2025 overdue | diaphragm disorder | Stanford University | Recruiting | No outcome recorded |
| Phase 2 | NCT03580343 | Apr → Dec 2019 | scleritis, uveitis | Washington University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT03598959 | Jan → Dec 2019 | extranodal nasal NK/T cell lymphoma | Sichuan University | Unknown | No outcome recorded |
| Phase 2 | NCT02812342 | Sep 2016 → Jul 2018 | alopecia areata, alopecia totalis, alopecia universalis | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT02299297 | Jan 2015 → Dec 2017 | alopecia areata | Columbia University | Completed | No outcome recorded |
| Phase 2 | NCT02197455 | Jul 2014 → Jul 2015 | alopecia areata, alopecia totalis, alopecia universalis | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT02147587 | Jun 2014 → Jun 2015 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02001181 | Dec 2013 → Sep 2014 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01831466 | May 2013 → Sep 2014 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01786668 | Apr 2013 → Mar 2015 | ankylosing spondylitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01710046 | Mar → Nov 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01470599 | Apr 2012 → Jul 2016 | Crohn disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01393899 | Mar 2012 → Jul 2015 | Crohn disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01393626 | Oct 2011 → Feb 2015 | Crohn disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01359150 | Sep 2011 → Feb 2012 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01246583 | Feb → Nov 2011 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01226680 | Dec 2010 → Oct 2012 | dry eye syndrome | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT01164579 | Oct 2010 → Nov 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01135511 | Jul 2010 → Apr 2011 | dry eye syndrome | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01059864 | Feb → Nov 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00976599 | Nov 2009 → Jul 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00687193 | Mar 2009 → Jul 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00787202 | Dec 2008 → Sep 2010 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00678561 | Oct 2008 → Jul 2009 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00658359 | Aug 2008 → Mar 2015 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00678210 | Jul 2008 → Aug 2009 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00603512 | Jan → Sep 2008 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00615199 | Jan 2008 → Oct 2009 | Crohn disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00550446 | Sep 2007 → Jan 2009 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00483756 | Aug 2007 → Feb 2010 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00556257 | Aug 2007 → ? | — | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT00413660 | Jan 2007 → Aug 2008 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00263328 | Dec 2005 → Jan 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00106639 | May 2005 → Jul 2006 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00147498 | Jan 2005 → Jun 2006 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT06011343 | Oct 2023 → Oct 2024 | cutaneous leishmaniasis | Hospital Universitário Professor Edgard Santos | Unknown | No outcome recorded |
| Phase 2/3 | NCT03738956 | Sep 2017 → Dec 2018 | spondyloarthropathy | Globe Pharmaceuticals Limited | Unknown | No outcome recorded |
| Phase 2/3 | NCT01500551 | Mar 2013 → Feb 2025 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 335 trials | ||||||
| Phase 3 | NCT07530367 | Apr 2026 → Apr 2028 expected | palmoplantar pustulosis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04871191 | Jun 2025 → Oct 2028 expected | granulomatosis with polyangiitis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT07008846 | May 2025 → Sep 2026 expected | rheumatoid arthritis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06172361 | Jan 2024 → Sep 2025 overdue | polymyalgia rheumatica | Zhejiang University | Recruiting | No outcome recorded |
| Phase 3 | NCT06278402 | Jul 2023 → Jan 2024 | alopecia areata, alopecia totalis, alopecia universalis | Jinnah Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | No outcome recorded |
| Phase 3 | NCT05749666 | Jan 2023 → Jul 2025 | Takayasu arteritis | Chinese SLE Treatment And Research Group | Unknown | No outcome recorded |
| Phase 3 | NCT05326464 | Oct 2022 → Feb 2025 | glioblastoma | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT04624230 | Aug 2021 → Apr 2027 expected | ulcerative colitis | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT04469114 | Sep 2020 → Jan 2021 | COVID-19 | Hospital Israelita Albert Einstein | Completed | No outcome recorded |
| Phase 3 | NCT03502616 | Jun 2018 → Dec 2019 | ankylosing spondylitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03000439 | May 2018 → Mar 2024 | systemic-onset juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03736161 | Sep 2017 → Sep 2019 | psoriatic arthritis | Globe Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 3 | NCT02592434 | Jun 2016 → May 2019 | juvenile idiopathic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02566967 | May 2015 → Dec 2017 | rheumatoid arthritis | Norman B. Gaylis, MD | Completed | No outcome recorded |
| Phase 3 | NCT01976364 | Feb 2014 → May 2019 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01877668 | Jan 2014 → Dec 2015 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01815424 | Dec 2013 → Jul 2015 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01470612 | Oct 2012 → Aug 2020 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01458574 | Jul 2012 → May 2016 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01458951 | Jun 2012 → May 2015 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01465763 | Apr 2012 → May 2015 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01519089 | Mar 2012 → Jan 2014 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01276639 | Mar 2011 → Apr 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01309737 | Mar 2011 → Apr 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01241591 | Nov 2010 → Jan 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01186744 | Sep 2010 → Jan 2013 | psoriasis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01163253 | Sep 2010 → Jun 2016 | psoriasis | Pfizer | Terminated | No outcome recorded |
| Phase 3 | NCT01039688 | Jan 2010 → Mar 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00856544 | May 2009 → Jan 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00853385 | May 2009 → Mar 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00814307 | Feb 2009 → Jun 2010 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00661661 | Apr 2008 → Dec 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00413699 | Feb 2007 → Nov 2016 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 436 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07636057 | Jul 2026 → Mar 2027 expected | rheumatoid arthritis | Sheikh Zayed Federal Postgraduate Medical Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07406204 | Feb → Aug 2026 overdue | alopecia areata, alopecia totalis, alopecia universalis | Hayat Abad Medical Complex, Peshawar | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07554820 | Dec 2025 → Aug 2026 overdue | rheumatoid arthritis | Shaikh Zayed Hospital, Lahore | Recruiting | No outcome recorded |
| Phase 4 | NCT07131813 | Oct 2025 → Jan 2027 expected | lichen planus, oral | All India Institute of Medical Sciences, Bhubaneswar | Recruiting | No outcome recorded |
| Phase 4 | NCT07160231 | Sep 2025 → May 2028 expected | psoriatic arthritis, spondyloarthropathy | Sint Maartenskliniek | Recruiting | No outcome recorded |
| Phase 4 | NCT06945666 | Aug 2025 → Jan 2027 expected | rheumatoid arthritis | Jie Chang | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06998875 | Mar → Oct 2025 overdue | primary cutaneous amyloidosis | Army Medical University, China | Recruiting | No outcome recorded |
| Phase 4 | NCT06465732 | Jan → Nov 2025 overdue | atopic eczema | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07472166 | Dec 2024 → Aug 2025 | systemic sclerosis | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT06660329 | Oct 2024 → Oct 2027 expected | Blau syndrome | Peking Union Medical College Hospital | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06498089 | Jun 2024 → Jun 2026 overdue | Takayasu arteritis | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06095128 | Jun 2024 → Jul 2027 expected | ulcerative colitis | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT06438679 | Mar → Sep 2024 overdue | dermatomyositis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06112665 | Nov 2023 → Mar 2025 overdue | spondyloarthropathy | Charite University, Berlin, Germany | Recruiting | No outcome recorded |
| Phase 4 | NCT05606107 | May 2022 → Jun 2024 | rheumatoid arthritis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT05313620 | Apr 2022 → Dec 2025 overdue | ulcerative colitis, venous thromboembolism | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Recruiting | No outcome recorded |
| Phase 4 | NCT06310057 | Jan 2022 → Mar 2024 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT05080218 | Nov 2021 → Apr 2024 | psoriatic arthritis, spondyloarthropathy | Jeffrey Curtis | Completed | No outcome recorded |
| Phase 4 | NCT05102448 | Nov 2021 → Dec 2025 overdue | Takayasu arteritis | Shanghai Zhongshan Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04944524 | Jul 2021 → Jul 2024 | granulomatosis with polyangiitis | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06146972 | Jun 2021 → Mar 2024 | rheumatoid arthritis | Yanfeng Hou | Unknown | No outcome recorded |
| Phase 4 | NCT04927000 | May 2021 → Aug 2022 | rheumatoid arthritis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04311567 | Nov 2020 → Nov 2023 | interstitial lung disease, rheumatoid arthritis | Vastra Gotaland Region | Terminated | No outcome recorded |
| Phase 4 | NCT04966884 | Apr 2020 → Dec 2021 | anti-MDA5 dermatomyositis | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 4 | NCT04299971 | Mar 2020 → Dec 2022 | Takayasu arteritis | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04928066 | Mar 2020 → Jun 2023 | rheumatoid arthritis | Qilu Hospital of Shandong University | Completed | No outcome recorded |
| Phase 4 | NCT04464642 | Jul 2019 → Aug 2020 | rheumatoid arthritis | Dr. Mohammad Mamun Khan | Unknown | No outcome recorded |
| Phase 4 | NCT03800979 | Jan 2019 → Jan 2021 | alopecia areata | Institute of Dermatology, Thailand | Completed | No outcome recorded |
| Phase 4 | NCT03281304 | Nov 2017 → Feb 2020 | ulcerative colitis | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT02831855 | Sep 2016 → Nov 2018 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02321930 | Feb 2016 → Sep 2017 | rheumatoid arthritis | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT02187055 | Aug 2014 → Dec 2016 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT02157012 | May 2014 → Apr 2022 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 4 | NCT02092467 | Mar 2014 → Jul 2020 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase not applicable12 trials | ||||||
| — | NCT07406932 | May 2026 → Jul 2027 expected | antisynthetase syndrome, interstitial lung disease | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| — | NCT07343635 | Feb 2026 → Jul 2027 expected | rosacea | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | No outcome recorded |
| — | NCT06707246 | Dec 2024 → Oct 2026 expected | hidradenitis suppurativa | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT06301373 | Sep 2024 → Dec 2029 expected | rheumatoid arthritis | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | No outcome recorded |
| — | NCT06201715 | May 2024 → Jun 2025 | prurigo nodularis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT06202560 | Nov 2023 → Jul 2024 | frontal fibrosing alopecia, lichen planopilaris | Institute of Dermatology, Thailand | Completed | No outcome recorded |
| — | NCT05112263 | Jul 2023 → Dec 2025 | ulcerative colitis | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| — | NCT06474078 | Aug 2022 → Jun 2025 | Stevens-Johnson syndrome | Chang Gung Memorial Hospital | Completed | No outcome recorded |
| — | NCT04378621 | Oct 2020 → Sep 2025 | depressive disorder, rheumatoid arthritis, subjective cognitive decline | Vastra Gotaland Region | Unknown | No outcome recorded |
| — | NCT04973033 | Dec 2019 → Jan 2021 | anti-neutrophil cytoplasmic antibody-associated vasculitis, substance abuse | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| — | NCT02312882 | Dec 2014 → Aug 2015 | alopecia areata, alopecia totalis, alopecia universalis | Stanford University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 35 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07261306 Comparator | Aug → Dec 2025 overdue | psoriasis | Lahore General Hospital | Recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT07044141 Comparator | Mar → Sep 2025 overdue | vitiligo | Lahore General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04552197 Comparator | Sep → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02535689 Comparator | Aug 2015 → Apr 2018 | systemic lupus erythematosus | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | No outcome recorded |
| Phase 1 | NCT01484561 Comparator | Apr 2012 → Jan 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03274076 Comparator | Sep 2017 → Apr 2019 | diffuse cutaneous systemic sclerosis, diffuse scleroderma | University of Michigan | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07406035 Comparator | Apr 2026 → Aug 2027 expected | psoriatic arthritis | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06176508 Comparator | Feb 2024 → Apr 2026 overdue | psoriatic arthritis | Hansoh BioMedical R&D Company | Recruiting | No outcome recorded |
| Phase 2 | NCT06114407 Comparator | Oct 2023 → Jun 2024 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase 2 | NCT05814939 Comparator | Apr 2023 → May 2024 | ankylosing spondylitis | Jiangsu vcare pharmaceutical technology co., LTD | Completed | No outcome recorded |
| Phase 2 | NCT05133297 Comparator | Feb → Dec 2022 | rheumatoid arthritis | Hangzhou Highlightll Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04062695 Comparator | Aug 2020 → Dec 2023 | arthritis, sacroiliac, psoriatic arthritis, spondylitis | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 2 | NCT03755466 Comparator | Nov 2018 → Nov 2023 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 2 | NCT02996500 Comparator | Nov 2016 → Aug 2018 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT06654882 Comparator | Jan → Dec 2026 expected | polyarticular juvenile idiopathic arthritis | Duke University | Recruiting | No outcome recorded |
| Phase 3 | NCT06020144 Comparator | Nov 2023 → Jan 2026 overdue | rheumatoid arthritis | Hangzhou Highlightll Pharmaceutical Co., Ltd | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04505410 Comparator | Sep 2020 → Dec 2023 | ulcerative colitis | University of Miami | Completed | No outcome recorded |
| Phase 3 | NCT03970837 Comparator | Jun 2019 → Oct 2021 | rheumatoid arthritis | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT03980483 Comparator | May 2019 → Sep 2021 | rheumatoid arthritis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03486457 Comparator | Aug 2018 → Apr 2021 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT02281552 Comparator | Nov 2014 → Mar 2017 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01882439 Comparator | Aug 2013 → Apr 2016 | psoriatic arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00960440 Comparator | Oct 2009 → Mar 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00847613 Comparator | Mar 2009 → Apr 2011 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06687551 Comparator | Jan 2025 → Apr 2029 expected | rheumatoid arthritis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06625450 Comparator | Oct 2024 → Dec 2025 overdue | ulcerative colitis | Post Graduate Institute of Medical Education and Research, Chandigarh | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05803135 Comparator | Mar 2023 → Jan 2025 | rheumatoid arthritis | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT05151848 Comparator | Jan 2022 → Jan 2026 | Takayasu arteritis | Chinese SLE Treatment And Research Group | Unknown | No outcome recorded |
| Phase 4 | NCT03976245 Comparator | Mar 2020 → Mar 2025 overdue | rheumatoid arthritis | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Recruiting | No outcome recorded |
| Phase 4 | NCT04485325 Comparator | Nov 2019 → Mar 2024 | rheumatoid arthritis | Dr. Frank Behrens | Completed | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03504072 Comparator | Jan 2018 → Jun 2019 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07581418 Comparator | Jun → Dec 2026 expected | psoriasis | Pak Emirates Military Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 47 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-12-14 | Pfizer | U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Ankylosing Spondylitis pfizer.com ↗ |
| 2021-11-18 | Pfizer | Pfizer’s XELJANZ® (tofacitinib) Receives Marketing Authorization in the European Union for the Treatment of Active Ankylosing Spondylitis pfizer.com ↗ |
| 2021-08-20 | Pfizer | XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis pfizer.com ↗ |
| 2021-07-21 | Pfizer | Pfizer Provides Update on U.S. FDA Review of Abrocitinib and XELJANZ® Filings pfizer.com ↗ |
| 2021-06-16 | Pfizer | Data Published in New England Journal of Medicine Shows Pfizer’s Tofacitinib Meets Primary Endpoint in Brazilian Study in Patients Hospitalized with COVID-19 Pneumonia pfizer.com ↗ |
| 2021-01-27 | Pfizer | Pfizer Shares Co-Primary Endpoint Results from Post-Marketing Required Safety Study of XELJANZ® (tofacitinib) in Subjects with Rheumatoid Arthritis (RA) pfizer.com ↗ |
| 2020-11-06 | Pfizer | Pfizer Announces Positive Phase 3 Study Results for XELJANZ ® (tofacitinib) in Ankylosing Spondylitis (AS) pfizer.com ↗ |
| 2020-09-28 | Pfizer | U.S. FDA Approves Pfizer’s XELJANZ® (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis pfizer.com ↗ |
| 2019-12-12 | Pfizer | FDA Approves XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis pfizer.com ↗ |
| 2019-11-12 | Pfizer | Pfizer Announces Results of Phase 3 Study for XELJANZ® (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting pfizer.com ↗ |
| 2019-06-12 | Pfizer | Pfizer Announces Results from XELJANZ® XR (tofacitinib) ORAL Shift Study, The First Phase 3b/4 Study to Evaluate Methotrexate Withdrawal with a JAK Inhibitor pfizer.com ↗ |
| 2018-08-01 | Pfizer | XELJANZ® (tofacitinib citrate) Receives Marketing Authorization in the European Union for Moderately to Severely Active Ulcerative Colitis pfizer.com ↗ |
| 2018-06-28 | Pfizer | XELJANZ® (tofacitinib citrate) Receives Marketing Authorisation in the European Union for Active Psoriatic Arthritis pfizer.com ↗ |
| 2018-05-30 | Pfizer | Pfizer Announces U.S. FDA Approves XELJANZ® (tofacitinib) for the Treatment of Moderately to Severely Active Ulcerative Colitis pfizer.com ↗ |
| 2018-03-08 | Pfizer | Pfizer Announces Favorable Outcome of FDA Advisory Committee Meeting on XELJANZ® (tofacitinib) for Moderately to Severely Active Ulcerative Colitis pfizer.com ↗ |
| 2017-12-18 | Takeda | Termination of Co-Promotion and Takeda's Distribution of 'Xeljanz ® Tablets 5 mg' in Japan takeda.com ↗ |
| 2017-12-14 | Pfizer | Pfizer Announces FDA Approval of XELJANZ® (tofacitinib) and XELJANZ® XR for the Treatment of Active Psoriatic Arthritis pfizer.com ↗ |
| 2017-12-12 | Pfizer | U.S. Food And Drug Administration Extends Action Date For XELJANZ® (Tofacitinib) Supplemental New Drug Application In Ulcerative Colitis By Three Months pfizer.com ↗ |
| 2017-10-16 | Pfizer | New Ulcerative Colitis Data for XELJANZ® (tofacitinib) at Upcoming Gastroenterology Congresses pfizer.com ↗ |
| 2017-08-03 | Pfizer | FDA Advisory Committee Votes in Favor of XELJANZ® (tofacitinib citrate) for the Treatment of Active Psoriatic Arthritis pfizer.com ↗ |
| 2017-07-13 | Pfizer | Pfizer Announces FDA Accepts Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis pfizer.com ↗ |
| 2017-06-16 | Pfizer | Pfizer Announces Results from XELJANZ® (tofacitinib citrate) ORAL Strategy Study Published in The Lancet and Presented at the EULAR Annual Congress pfizer.com ↗ |
| 2017-05-03 | Pfizer | Phase 3 OCTAVE Studies of Oral Tofacitinib in Ulcerative Colitis Results Published in The New England Journal of Medicine pfizer.com ↗ |
| 2017-05-03 | Pfizer | Pfizer Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Active Psoriatic Arthritis pfizer.com ↗ |
| 2017-03-27 | Pfizer | XELJANZ® (tofacitinib citrate) Receives Marketing Authorisation in the European Union for the Treatment of Moderate to Severe Active Rheumatoid Arthritis (RA) pfizer.com ↗ |
| 2017-03-15 | Pfizer | Pfizer Announces Approval By The China Food And Drug Administration Of XELJANZ®, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis pfizer.com ↗ |
| 2017-02-16 | Pfizer | Pfizer Announces Top-Line Results from the Oral Strategy Trial of XELJANZ® (tofacitinib citrate) Compared to Humira® (adalimumab) pfizer.com ↗ |
| 2017-01-27 | Pfizer | Pfizer Receives Positive CHMP Opinion in Europe for XELJANZ® (tofacitinib citrate) for the Treatment of Moderate to Severe Active Rheumatoid Arthritis pfizer.com ↗ |
| 2016-11-15 | Pfizer | Pfizer Announces Results from Phase 3 OPAL Clinical Development Program Investigating XELJANZ® (Tofacitinib Citrate) for Psoriatic Arthritis pfizer.com ↗ |
| 2016-11-07 | Pfizer | Pfizer to Present Additional Research For XELJANZ® (Tofacitinib Citrate) In Rheumatologic Diseases, Including Rheumatoid Arthritis and Psoriatic Arthritis pfizer.com ↗ |
| 2016-10-15 | Pfizer | Pfizer to Present New Data on XELJANZ® (Tofacitinib Citrate) for Ulcerative Colitis at UEG Week 2016 pfizer.com ↗ |
| 2016-07-28 | Pfizer | Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) in Ulcerative Colitis pfizer.com ↗ |
| 2016-06-08 | Pfizer | Pfizer Research Advances Body Of Evidence For Tofacitinib Citrate (XELJANZ®) Providing Clinicians With Additional Information For The Treatment Of Moderate to Severe RA pfizer.com ↗ |
| 2016-06-07 | Pfizer | Pfizer Announces Positive Top-Line Results from Second Phase 3 Trial of Oral XELJANZ® (Tofacitinib Citrate) in Adults with Psoriatic Arthritis pfizer.com ↗ |
| 2016-04-05 | Pfizer | Pfizer Announces Positive Top-Line Results from the First Phase 3 Trial of Investigational Tofacitinib in Adults with Psoriatic Arthritis pfizer.com ↗ |
| 2016-03-23 | Pfizer | Pfizer Announces European Medicines Agency Accepted for Review Its Marketing Authorization Application for XELJANZ® (Tofacitinib Citrate) for the Treatment of Moderate to Severe Rheumatoid Arthritis pfizer.com ↗ |
| 2016-03-18 | Pfizer | Pfizer Announces Oral Tofacitinib, an Investigational JAK Inhibitor, Meets Primary and Key Secondary Endpoints in Two Pivotal Phase 3 Ulcerative Colitis Trials pfizer.com ↗ |
| 2016-03-16 | Pfizer | Pfizer to Present New Data on Investigational Tofacitinib in Inflammatory Bowel Disease at the 11th Congress of ECCO pfizer.com ↗ |
| 2016-02-24 | Pfizer | Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis pfizer.com ↗ |
| 2015-11-02 | Pfizer | New Data Continue to Characterize the Safety and Efficacy of XELJANZ® (tofacitinib citrate) in the Treatment of Rheumatoid Arthritis pfizer.com ↗ |
| 2015-10-14 | Pfizer | Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ® (tofacitinib citrate) Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis pfizer.com ↗ |
| 2015-09-21 | Pfizer | Pfizer Announces Positive Top-Line Results from Two Phase 3 Trials of Oral Tofacitinib in Adults with Moderate-to-Severe Ulcerative Colitis pfizer.com ↗ |
| 2015-07-02 | Pfizer | Pfizer Announces FDA Acceptance for Review of New Drug Application for A Once-Daily Formulation of XELJANZ® (tofacitinib citrate) Modified Release Tablets pfizer.com ↗ |
| 2015-06-10 | Pfizer | Pfizer Builds Upon Robust Body Of Knowledge For XELJANZ® (tofacitinib citrate) With Clinical Trial And Real-World Use Data At The European League Against Rheumatism Annual Congress (EULAR 2015) pfizer.com ↗ |
| 2015-06-08 | Pfizer | Pfizer Announces 12 Presentations Including New Research Data on Tofacitinib for Chronic Plaque Psoriasis and Atopic Dermatitis at World Congress of Dermatology pfizer.com ↗ |
| 2015-03-20 | Pfizer | Pfizer Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials pfizer.com ↗ |
| 2015-02-04 | Pfizer | Pfizer Announces FDA Acceptance For Review Of Supplemental New Drug Application For Oral XELJANZ® (tofacitinib citrate) For Adult Patients With Moderate To Severe Chronic Plaque Psoriasis pfizer.com ↗ |
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 256 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tofacitinib | “One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2,...” PMID 22894574 ↗ Aug 2012193“A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid...” PMID 22006202 ↗ Oct 2011 “This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when...” NCT02084875 ↗ “The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab....” NCT04114461 ↗ “We randomly assigned 958 patients to receive 5 mg or 10 mg of tofacitinib twice daily or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks;...” PMID 24941177 ↗ Jun 2014 “Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a...” PMID 23294500 ↗ Jan 2013 “Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid...” NCT07406932 ↗ “Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite...” NCT04692493 ↗ “Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.” PMID 22873530 ↗ Aug 2012 “BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon.” NCT06275464 ↗ “Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study.” PMID 23348607 ↗ Mar 2013 “Tofacitinib (CP-690,550) is a novel Janus kinase inhibitor in development as an oral formulation for the treatment of several inflammatory diseases including psoriasis.” PMID 23387374 ↗ Jul 2013 “The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).” NCT01484561 ↗ “new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).” NCT04505410 ↗ “Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated for the treatment of rheumatoid arthritis.” PMID 22873531 ↗ Aug 2012 “Immunomodulatory effect of the topical ophthalmic Janus kinase inhibitor tofacitinib (CP-690,550) in patients with dry eye disease.” PMID 22607938 ↗ May 2012 “Tofacitinib, a Janus kinase(JAK) inhibitor-2 has shown promising results in the treatment of vitiligo.” NCT05293119 ↗ “Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA).” PMID 33127856 ↗ Oct 2020 “Tofacitinib is an oral disease-modifying anti-rheumatic drug to selectively inhibit Janus kinases.” PMID 33062629 ↗ Sep 2020 “Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA).” PMID 31512746 ↗ Sep 2019 “Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA).” PMID 32048083 ↗ Feb 2020 “Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA).” PMID 31512746 ↗ Sep 2019 “treated with JAK inhibitors (upadacitinib 15mg qd/tofacitinib 5mg bid)orally for 28 days” NCT07530224 ↗ “Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis.” PMID 27129117 ↗ Oct 2014 “CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition” NCT03858725 ↗ “JAK-inhibitors: Baricitinib (Olumiant), Tofacitinib (Xeljanz)” NCT04378621 ↗ “Tofacitinib 5 mg twice daily OR Tofacitinib 11 mg once daily” NCT07160231 ↗ “2. Tofacitinib 5 mg twice daily for 12 months.” NCT04966884 ↗ “oral tofacitinib will be taken 2 times daily” NCT02566967 ↗ “Methotrexate or leflunomide + Tofacitinib or” NCT02714634 ↗ “Tofacitinib (CP-690,550) 10 mg BID plus MTX” NCT01164579 ↗ “tofacitinib (JAK1/3 inhibitor) 5 mg po bid” NCT05305066 ↗ “Iguratimod 25mg bid + tofacitinib 5mg bid” NCT06146972 ↗ “Tofacitinib, baricitinib, or upadacitinib” NCT05379322 ↗ “Tofacitinib is used according to weight” NCT06660329 ↗ “CP-690,550 (tofacitinib)” NCT01745055 ↗ “tofacitinib” NCT03504072 ↗ |
| Known as | CKD-374 | “CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition” NCT03858725 ↗ |
| Known as | CP-6890,550 | “(CP-6890,550) Tofacitinib” NCT01710046 ↗ |
| Known as | CP-690 | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | CP-690 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | CP-690,55 | “Tasocitinib (CP-690,55) plus Ketoconazole” NCT01202240 ↗ |
| Known as | CP-690,550 | “One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2,...” PMID 22894574 ↗ Aug 201276“A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN...” NCT03486457 ↗ “Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an...” PMID 21952978 ↗ Mar 2012 “This study will evaluate the drug behavior and safety of a single dose of the 22 milligram tofacitinib (CP-690,550) modified-release formulation in 18 healthy volunteers when...” NCT02487433 ↗ “This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when...” NCT02084875 ↗ “A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And...” NCT01882439 ↗ “This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30...” NCT01499004 ↗ “Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for rheumatoid arthritis.” PMID 22873530 ↗ Aug 2012 “Tofacitinib (CP-690,550) is a novel Janus kinase inhibitor in development as an oral formulation for the treatment of several inflammatory diseases including psoriasis.” PMID 23387374 ↗ Jul 2013 “This is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (CP-690,550) in the subjects with moderate to severe dry eye disease.” NCT01226680 ↗ “A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients” NCT00556257 ↗ “OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS” NCT04624230 ↗ “Tofacitinib (CP-690,550) is a novel oral Janus kinase inhibitor that is being investigated for the treatment of rheumatoid arthritis.” PMID 22873531 ↗ Aug 2012 “a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions.” NCT01184001 ↗ “A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS” NCT01976364 ↗ “CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks” NCT01241591 ↗ “Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet” NCT01143805 ↗ “Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)” NCT01277991 ↗ “tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment” NCT02147587 ↗ “tasocitinib (CP-690,550) as a single oral 10 mg dose” NCT01202240 ↗ “Tasocitinib (CP-690,550) 30 mg (single oral dose)” NCT01204112 ↗ “Tofacitinib (CP-690,550) 10 mg BID plus MTX” NCT01164579 ↗ “10 mg, single dose of CP- 690,550 on Day 1” NCT00860496 ↗ “on the JAK inhibitor, CP-690,550.” NCT00860496 ↗ “(CP-690,550) Tofacitinib” NCT01710046 ↗ “CP-690,550 (tofacitinib)” NCT02592434 ↗ “Drug: CP-690, 550” NCT01519089 ↗ “Drug: CP690,550” NCT01458574 ↗ |
| Known as | CP-690,550 FREE BASE | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | CP-690,550-10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | Cp-690550 citrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | PFE-PKIS 25 | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | tasocitinib | “a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy subjects on two separate dosing occasions.” NCT01184001 ↗ |
| Known as | tasocitinib citrate | “Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet” NCT01184092 ↗ |
| Known as | Tasocitinib monocitrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | TOF | “This post hoc analysis assessed the effect of baseline C-reactive protein (CRP) on the efficacy and safety of tofacitinib (TOF) use in ankylosing spondylitis (AS), as well as...” PMID 38825359 ↗ Aug 20241“OBJECTIVE: To evaluate the effect of tofacitinib (TOF) on American College of Rheumatology (ACR) response criteria components in patients with rheumatoid arthritis (RA).” PMID 35232809 ↗ Mar 2022 |
| Known as | TOFA | “either Tofacitinib (TOFA) or etanercept (ETA).” NCT04485325 ↗ |
| Known as | TOFACITINIB (CONTROLLED RELEASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | TOFACITINIB (CP-690550) | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | tofacitinib citrate | “In 2014, the first reported case using a JAK1/3 inhibitor, tofacitinib citrate, for the treatment of AU was described in a patient with concomitant plaque psoriasis who...” NCT06278402 ↗3“using the pan-JAK inhibitor, tofacitinib citrate, for AA with >50% scalp hair loss, alopecia totalis (AT), and alopecia universalis (AU).” PMID 27699252 ↗ Sep 2016 “Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months.” NCT06157905 ↗ “Drug: Tofacitinib Citrate” NCT05487963 ↗ |
| Known as | Tofacitinib monocitrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | XELJANZ | “This study aimed to evaluate the bioequivalence of the pharmacokinetics (PK) between tofacitinib aspartate 7.13 mg (test formulation) and tofacitinib citrate 8.08 mg (reference...” PMID 33062629 ↗ Sep 20209“A novel treatment for these refractory cases is tofacitinib (Xeljanz®), a synthetic small molecule inhibitor of JAK kinases” NCT05313620 ↗ “Single Oral Administration of Xeljanz 5 mg Tablet” NCT04468425 ↗ “Tofacitinib (Xeljanz®; 5 mg twice daily, p.o.)” NCT04485325 ↗ “Tofacitinib 10 MG [Xeljanz]” NCT03681275 ↗ “Tofacitinib 10 MG [Xeljanz]” NCT04925973 ↗ “Tofacitinib 5 MG [Xeljanz]” NCT04141904 ↗ “Tofacitinib 5 MG [Xeljanz]” NCT03755466 ↗ “XELJANZ (tofacitinib)” NCT05104723 ↗ |
| Known as | Xeljanz xr | ChEMBL registry synonym — accepted as the source's own label CHEMBL221959 ↗ |
| Known as | XELJANZ(R) | “XELJANZ(R) is the citrate salt of tofacitinib.” NCT04496960 ↗ |
| Action | Inhibit | “Janus kinase inhibitor CP-690,550” PMID 19660021 ↗ Aug 2009 |
| Modality | Small molecule | “Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC).” PMID 32816215 ↗ Aug 2020 |
| Route | Oral | “Oral tablets administered at a dose of 5 mg BID for 6 weeks” NCT00147498 ↗ |
| Target | JAK3 | “JAK3 inhibitor” NCT00556257 ↗ |